Recruiting
Phase 2
Phase 3

5-Fluorouracil & Calcipotriene

Sponsor:

Boston University

Code:

NCT05381597

Conditions

Superficial Basal Cell Carcinoma

Squamous Cell Carcinoma in Situ

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Combination cream of 5-fluorouracil and calcipotriene

5-fluorouracil cream

Study Details

Brief summary:

The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers.

The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with

The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.

Conditions

Superficial Basal Cell Carcinoma

Squamous Cell Carcinoma in Situ

Study ID

NCT05381597

Start date

Oct 15, 2022

Status verified date

Nov, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English-speaking
  • Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin <2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
  • Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
  • Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
  • Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other
  • If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy.

Exclusion Criteria:

  • Current or prior field treatment within 2 cm of the target BCC or SCCis
  • Periorbital lesions
  • Lesions that have been previously treated
  • Known allergy to any of the study medication ingredients
  • History of solid organ transplant or current immunosuppression
  • Genetic disorders associated with high skin cancer risk
  • Arsenic exposure
  • Cutaneous T-cell lymphoma
  • Current or prior radiation therapy at the site of the sBCC or SCCis
  • Women who are pregnant or currently breastfeeding
  • Prior psoralen plus Ultraviolet light (UVA) treatment at the site
  • Very high mortality risk at the start of the study
  • Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
  • Demonstrated hypercalcemia or evidence of vitamin D toxicity
  • Lesions that extend into the oral, nasal or genital mucosa

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Combination cream of 5-fluorouracil and calcipotriene

Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.

active comparator: 5-fluorouracil cream

Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.

Interventions

Combination cream of 5-fluorouracil and calcipotriene

Apply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.

5-fluorouracil cream

Apply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days.

Primary outcome measure

  • Clearance rate of cancer lesions at 3 months [ Time Frame: 3 months ]
  • Clearance rate of cancer lesions at 3 years [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Frederick Gibson, MD

(617) 358-9700frederick.gibson@bmc.org

Alexandria Riopelle, MD

(617) 358-9700alexandria.riopelle@bmc.org

Locations

Boston Medical Center Dermatology Clinic

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Bilal Fawaz, MD

617-358-9700bilal.fawaz@bmc.org

Frederick Gibson, MD

(617) 358-9700frederick.gibson@bmc.org

Principal Investigator:

Bilal Fawaz, MD

More Information

Sponsor

Boston University

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • 5-fluorouracil cream
  • fluorouracil with calcipotriene

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2025-11-28.